Laser eye surgery not so great after all?

[Darth Wong]

Link

FDA takes closer look at Lasik complaints

WASHINGTON (AP) -- Lost in the hoopla of ads promising that laser vision surgery lets you toss your glasses is a stark reality. Not everyone's a good candidate, and an unlucky few do suffer life-changing side effects: lost vision, dry eye, night-vision problems.

A decade after Lasik hit the market, unhappy patients will air their grievances before the Food and Drug Administration on Friday as the government begins a major new effort to see whether warnings about the risks are strong enough.

How big are those risks? The FDA thinks that about 5 percent of patients are dissatisfied, but it can't provide more specifics -- and is pairing with eye surgeons for a major study expected to enroll hundreds of Lasik patients to try to better understand who has bad outcomes and exactly what their complaints are.

"Clearly, there is a group who are not satisfied and do not get the kind of results they expect," FDA medical device chief Dr. Daniel Schultz said Thursday. The study should "help us predict who those patients might be before they have the procedure."

About 7.6 million Americans have undergone some form of laser vision correction, including the $2,000-per-eye Lasik. Lasik is quick and, if no problems occur, painless: Doctors cut a flap in the cornea -- the clear covering of the eye -- aim a laser underneath it and zap to reshape the cornea for sharper sight.

The vast majority, 95 percent, of patients see more clearly after Lasik -- some better than 20/20 -- and are happy they had it, said Dr. Kerry Solomon of the Medical University of South Carolina, who led a review of Lasik's safety for the American Society of Cataract and Refractive Surgery.

But one in four patients who seeks Lasik is told that he or she is not a good candidate, he said. And there is little information about just how badly the 5 percent who are dissatisfied actually fare.

Solomon estimates that fewer than 1 percent of patients have severe complications that leave poor vision. Other side effects, however, are harder to pin down. Dry eye, for instance, can range from an annoyance to problems so severe that people suffer intense pain and need surgery to retain what little moisture their eyes form. That's the kind of question the FDA's new study aims to answer.

Dry eye is common even among people who never have eye surgery, and it increases as people age. Solomon says that 31 percent of Lasik patients have some degree of it before the surgery and that about 5 percent worsen afterwards.

But dry-eye specialist Dr. Craig Fowler of the University of North Carolina says other research suggests that 48 percent of patients experience some degree of dry eye at least temporarily after Lasik. Cutting the corneal flap severs nerves responsible for stimulating tear production, and how well those nerves heal in turn determines how much dry eye lingers long-term, he said.

Even if the risks are low, that's little consolation to suffering patients.

"As long as you know any ophthalmologist that's wearing glasses, don't get it done," says Steve Aptheker, 59, a Long Island lawyer who was lured by an ad for $999 Lasik and suffered severe side effects that required seven surgeries over four years to restore his vision.

The flaps cut in his cornea literally became wrinkled when they were laid back down, blocking his vision and causing severe pain. A few surgeries later, with a different doctor, Aptheker could function better but couldn't drive at night and saw a halo around objects, which caused serious distortion even during the day. With more operations as new technology hit the market, Aptheker said, today his right eye sees as well as it did with glasses before Lasik, but his left remains fuzzy and requires halo-reducing drops.

The FDA has long known of those side effects and thus for years has a Web site with warnings for Lasik patients and required that doctors give every potential patient a brochure outlining risks. Friday, the agency will ask its outside advisers whether its warning efforts go far enough.

But Lasik has been refined in recent years to offer crisper vision with fewer risks, said Dr. Steven Schallhorn, an ophthalmologist who oversaw the Navy's refractive surgery program until last year when, based in part on his research, the Navy began allowing its aviators to get Lasik.

Schallhorn advises patients to seek "all-laser Lasik," in which a thin flap is created using a more precise laser instead of a blade, combined with "wavefront-guided" software that maps subtle irregularities in the cornea before it's zapped.

Why don't laser eye clinics have to state the health risks in their ads, the way drug companies do? A 5% complication rate is pretty high: that's one out of twenty.

[PeZook]

What do you mean, why?

If it was so significant, the free market would've corrected it easily! I mean, customers would simply go elsewhere for their incredibly expensive laser eye surgery, or some intrepid enterpreneur would form his own clinic with better service!

...

It really doesn't take any thought.

Anyway, I'm surprised nobody did that study earlier. It is a minor surgical procedure, but performed on one of the most important and delicate organs in the human body.

It should be closely evaluated just as drugs are...

[General Zod]

This seems to fit with what I've heard about people being turned down because they weren't viable candidates for having it done due to something about their vision problems, so I can't say it's surprising. As if the $1,500 price tag per eye with insurance alone wasn't off-putting enough.

[Colonel Olrik]

Why don't laser eye clinics have to state the health risks in their ads, the way drug companies do? A 5% complication rate is pretty high: that's one out of twenty.

It's not a 5% complication rate, it's 5% of the people dissatisfied, which means they didn't improve significantly or at all. The complication rate is actually lower than 1%. I've been following the evolution of these operation for a decade, since I have -4.5 in both eyes and wear contacts all day. It's important to go to a trustworthy place and do the proper examinations before the operation, and only go through it if they're OK. The small potential of disaster is also why, AFAIK, you get each eye operated at separate times.

Taking all these precautions I'm willing to bet I'm not going to be in the 1% group, though I'm not in a particular hurry - my eyesight seems to have stabilized but technology is still getting better each year that passes. But you're right, the industry is too little unsupervised, at least in the US. In my recent trip in California, I was impressed by the amount of advertising that makes it sound like some minor cosmetic operation with a cheap pricetag. Here they take it more seriously.

"As long as you know any ophthalmologist that's wearing glasses, don't get it done," says Steve Aptheker, 59, a Long Island lawyer who was lured by an ad for $999 Lasik and suffered severe side effects that required seven surgeries over four years to restore his vision.

You shouldn't go for the "less than 1000 bucks!" ads if the ad is about lasering your eyes.

[The Spartan]

I suspect that part of the reason that there's such a high dissatisfaction rate is that people shop around for the cheapest price, not the best doctor.

When I had mine done I asked around to see who optometrists thought I should go see. They all said the same guy. Was it more costly? Yeah, much more. But I had 5 different doctors examine me and review my tests that day if you include my optometrist (who was having one of his eyes done the same day no less and observed my surgery) and the only complication I've had was some dry eye which has corrected itself to what it was before I had it done.

My sister went to the same place and her only complication was some cloudiness that cleared after a couple days and a flap that took a little longer to heal than mine. But that was because she didn't follow the directions properly and sat up watching TV that day instead of lying with her eyes closed like I did.

My sister-in-law on the other hand, went to a less costly place and got a very bad vibe from them, so, even though they said she was the perfect candidate she decided to get a second opinion. Good thing she did, because the second doctor said her sclera was way too thin for LASIK and that had she had it done it would have been, in his words, "disastrous."

[Alferd Packer]

Isn't LASIK just one of several treatments? It's just the most popular because it's the least invasive.

[Mange]

Isn't LASIK just one of several treatments? It's just the most popular because it's the least invasive.

No, PRK and LASEK is less invasive than LASIK and does not involve making a physical cut by surgical instruments in the cornea as LASIK does. The drawback is that the healing period is longer (a couple of weeks plus the fact that it takes some time, between one and three months, before the best visual acuity is at its best as compared with LASIK where the improvement is virtually instantaneous and the healing period is a few days. However, there's less complications with LASEK.).

[Singular Intellect]

Thankfully I live in Calgary, so when I get it done I'm having it done at the Gimbel centre.

From everything I've heard, they're world renowned and if any of the other laser eye facilities fuck up, they send you there. It's more expensive, but who in their right mind puts a price on good eyesight?

[LMSx]

I was thinking about this sort of surgery a couple of months ago, then looked over some side-effects and realized that even if the worst possibilities are rare, contact lenses and glasses just aren't that bad. Besides, the technology is probably only going to improve in the future.

[Kanastrous]

My cousin is an ophthalmic surgeon who snarls at the very mention of the procedure.

My ophthalmologist won't even give me straight answer on what he thinks of the procedure, but his expression makes it clear that he doesn't endorse the procedure.

A friend recently had LASIC performed by a high-end practice in Beverly Hills (apparently he was steered to them as 'the best in LA') and his complications were severe, he had to go in for a re-do, and he doesn't find his vision terribly improved.

All anecdotal, but enough to dim my enthusiasm for having it done, myself.

[Phantasee]

Thankfully I live in Calgary, so when I get it done I'm having it done at the Gimbel centre.

From everything I've heard, they're world renowned and if any of the other laser eye facilities fuck up, they send you there. It's more expensive, but who in their right mind puts a price on good eyesight?

I'm probably going to get it done there as well, in a few years. My vision hasn't been stable for long enough to consider it fully stable.

[FSTargetDrone]

I've been wearing glasses since the 3rd grade (I'm 33 now) and I'm in no hurry to get such a procedure. I don't want the bother of contacts and I've been wearing glasses for so long now, it seems strange to not have them resting on the top of my nose.

Has anyone else here considered the procedure, or gone through with it?

[The Grim Squeaker]

I've had glasses for ages, and i'm very sensitive to contacts, I did consider it, but a friend of my parents, the youngest Eye doctor in the country pretty much put it this way (While wearing her glasses):
"So far, no one knows what will happen after a few decades and the eye aging. And I'm still with glasses".

Hmm, not a very good transcript, but the point stands.

[mizuno]

I had PRK done at the Baylor Eye Center in Houston by one of the top 10 refractive eye surgeons in the country and I cam completely satisfied with the procedure. Before the operation I was nearly blind and now I can almost see 20/20 and have no haze at night. Once in a while my eye might be a little dry but nothing that a few eye drops can't fix. And I like this much better then all the crap I had to deal with wearing hard contacts, no inflammations, my eye feels less dry, and on windy days I don't feel like the contacts are cutting into my eye.

Honestly I think most of the dissatisfied customers are due to incompetent or dishonest surgeons. The first guy I went to didn't even examine me very much and kept on trying to push me into getting LASIK.. like a salesperson Then I go to the Baylor center and after doing much more extensive testing did I find out that my cornea is too thin for LASIK and I was an ideal candidate for PRK instead. My doc told me that they turn away around 20-30% of the people they see because they aren't good candidates, I suppose that is the honestly you'll get when your doc is a college professor and in it mostly for the research and not a sleazeball trying to make $$ off you. When you're messing around with something as important as your vision, don't halfass it and go for the cheapest person in the paper.. find someone who is very experienced and someine you can trust.

[SCRawl]

A good friend of mine had the surgery (Lasik, I think) a few years back, and he doesn't regret the decision. (I think that it was corrected to something like 20/16, but I'm not sure.) All told, it cost him a few thousand bucks, but he's a consulting engineer, and pulls down some pretty decent coin.

[Meest]

Does this take into consideration the earlier generations of the procedures? From what I understand the new generation of laser and procedures are a lot better. Only complaints I heard of from friends and family are ones that got it done years ago, the few that got it done recently say it's fine.

[mr friendly guy]

LASIK is something I have been considering since my vision is not that crash hot. However it seems to have stabilised. I am in no hurry so I will wait and see what this investigations show.

[Mange]

LASIK is something I have been considering since my vision is not that crash hot. However it seems to have stabilised. I am in no hurry so I will wait and see what this investigations show.

Then why not PRK/LASEK?

[Jadeite]

I've been wearing glasses since the 3rd grade (I'm 33 now) and I'm in no hurry to get such a procedure. I don't want the bother of contacts and I've been wearing glasses for so long now, it seems strange to not have them resting on the top of my nose.

Has anyone else here considered the procedure, or gone through with it?

I'm considering getting it done this summer. My eyesight is pretty bad, and I have trouble getting contacts off of my eyes, so I wear glasses instead. I'd rather not have to wear them the rest of my life, and I'd love the chance to have normal vision again.

[FSTargetDrone]

I'm considering getting it done this summer. My eyesight is pretty bad, and I have trouble getting contacts off of my eyes, so I wear glasses instead. I'd rather not have to wear them the rest of my life, and I'd love the chance to have normal vision again.

I remember when my parents would place their non-disposable contact lenses in these little cases with a cleaning solution inside, and then put the cases in a special electrical heater device that sterilized the lenses overnight (well, I assume that's what it was for!). Now, it all seems a lot simpler with disposable kinds. My girlfriend needs corrective lenses and hates glasses (though I think she looks great with them), so she uses disposable contacts. I just can't be bothered. Besides, I think glasses suit me, somehow.

[mr friendly guy]

LASIK is something I have been considering since my vision is not that crash hot. However it seems to have stabilised. I am in no hurry so I will wait and see what this investigations show.

Then why not PRK/LASEK?

I must admit I haven't seen these advertised over here so I am not too familiar with them.

[Broomstick]

Why don't laser eye clinics have to state the health risks in their ads, the way drug companies do? A 5% complication rate is pretty high: that's one out of twenty.

It's not a 5% complication rate, it's 5% of the people dissatisfied, which means they didn't improve significantly or at all. The complication rate is actually lower than 1%.

It depends on how you define "complication". If you have a surgical procedure to correct something and it's not corrected (for whatever reason) a layperson may well consider that a "complication" even if medical people don't. There are other potential issues, such as people who are able to test as 20/20 on an eye chart post-surgery, which some doctors count as a "success", but who experience haze or dry eyes or whatever afterward, which the patient regards as a problem. Dry eyes IS a complication, and a common one, but for most who experience it, it's a minor complication that goes away. There is also a variation where one eye is corrected for near and one for far vision to avoid the need for bifocals - the problem is, a significant portion of the population can not adjust to this (with men having more trouble with it than women) and wind up needing glasses in order to correct the "correction". The way to weed out these folks is quite simple, have them wear contacts for a few weeks that simulate the results to see if they are able to adjust but it's not done as often as it should be because of time, expense, and inconvenience - as if having your vision screwed up isn't inconvenient. You can remove or alter glasses and contacts, but not LASIK. Sorry, some people should just accept reading glasses really are their best option at this time.

But yes, the potential risks SHOULD be advertised. It's made me angry for years that this is treated so lightly by some, and people are not aware of the risks the way they should be.

The small potential of disaster is also why, AFAIK, you get each eye operated at separate times.

In the US it's common both are done at the same time, and I've known people who insisted on having both done on the same day.

I've had glasses for ages, and i'm very sensitive to contacts, I did consider it, but a friend of my parents, the youngest Eye doctor in the country pretty much put it this way (While wearing her glasses):
"So far, no one knows what will happen after a few decades and the eye aging. And I'm still with glasses".

Actually, it IS known that presbyopia will set in at some point - that's "old people's eyes" - and those who enjoy their new, perfect vision in their 20's and 30's may well wind up with reading glasses (at least) in their 40's or 50's. It also does nothing to reduce the odds of cataracts. So at the very least we know it won't prevent those very normal changes.

I had PRK done at the Baylor Eye Center in Houston by one of the top 10 refractive eye surgeons in the country and I cam completely satisfied with the procedure. Before the operation I was nearly blind and now I can almost see 20/20 and have no haze at night.

I'm not 100% sure, but I think PRK is less likely to result in haze anyway. Clearly, your doctor chose a procedure appropriate for you - too many "eye clinics" seem to take a one-size-fits-all approach.

Honestly I think most of the dissatisfied customers are due to incompetent or dishonest surgeons.

Well, a certain number of people WILL have problems, simply because it is a surgical procedure and you're dealing with biological systems in the real world. Even the best surgeons have bad outcomes sometimes, the mere fact something went wrong is not proof of incompetence or negligence in surgery. A pattern of problems might be an indication ... or it might mean the procedure is not as good as once thought.

The first guy I went to didn't even examine me very much and kept on trying to push me into getting LASIK.. like a salesperson

I've had acquaintances as well as "eye care professionals" try to pressure me into LASIK, but I already know I am a poor candidate with more than one risk factor for complications. Glasses are not nearly as inconvenient as not being able to see, ya know? My vision is correctable to 20/20 with glasses, and wearing glasses does not impede me in doing what I want to do in life. I would only consider vision correction surgery if my vision was no longer correctable with glasses.

Does this take into consideration the earlier generations of the procedures? From what I understand the new generation of laser and procedures are a lot better. Only complaints I heard of from friends and family are ones that got it done years ago, the few that got it done recently say it's fine.

Not sure, but "better" does not mean "without risk". Complications still occur. I had a co-worker about three years ago who had it done and wound up with worse vision than before, and though much of the problem is correctable with glasses, he still has problems. Was that due to incompetence, him being a poor candidate, or just bad luck? I have no idea. But in medicine complications can and do occur even under the best of circumstances.

Part of the problem with these various vision correction procedrues is that, while MOST people get good results, when things go bad they can go horribly bad, with people being rendered functionally blind, needing cornea transplants, and so on. I don't object to people taking informed risks, and as I said, for many people this is a good thing, but even a 1% complication rate is a serious problem given the importance of vision and the number of people we're talking about.

[Colonel Olrik]

There are other potential issues, such as people who are able to test as 20/20 on an eye chart post-surgery, which some doctors count as a "success", but who experience haze or dry eyes or whatever afterward, which the patient regards as a problem. Dry eyes IS a complication, and a common one, but for most who experience it, it's a minor complication that goes away.

Agreed. It's not like people do this operation because they're bored, in any case. I already have complications. Being almost functionally blind if I lose (only one of) my contact lenses or the glasses (and due to Murphy's law it has happened, and always at the worst possible moment) is a pretty huge complication, having to care about dry eyes if in a smoky place with contacts, having to put and remove them at least a couple time a days all count as complications, not to mention the cost involved.

In the US it's common both are done at the same time, and I've known people who insisted on having both done on the same day.

Funny, maybe things have changed or are just different, the 10 people or so I've met so far with whom I talked about this all had the operation in different days. Admittedly, it was some years ago.

[Crown]

Thanks for posting this article Mike. I'm also contemplating Laser Eye Surgery at the moment, and was wondering what the long term side affects are. Olrik, Broomstick, do you guys have any useful links that I can use for further reading? Or anyone else for that matter?

[Singular Intellect]

Thanks for posting this article Mike. I'm also contemplating Laser Eye Surgery at the moment, and was wondering what the long term side affects are. Olrik, Broomstick, do you guys have any useful links that I can use for further reading? Or anyone else for that matter?

Here. These are the guys I'm going to use.